FDA-Device2018-05-02Class II
Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test
Roche Diagnostics Corporation
Hazard
The previous version of method sheets for the Acetaminophen assay on the COBAS INTEGRA 400 plus/800/800 CTS analyzers and the MODULAR ANALYTICS P module are missing the following statement in the Limitations-interference section: "In very rare cases, gammopathy, in particular type IgM (Waldenstr¿m s macroglobulinemia), may cause unreliable results."
Sold states
Nationwide Distribution
Affected count
35,111
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1519-2018Don't want to check this manually?
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